How To Prove (Or Improve) The Trustworthiness Of Your Medical Devices

Med Device Online

John Giantsidis, president, CyberActa, Inc.

As medical devices grow in complexity and become increasingly interconnected through networks and communication links, their vulnerability to attacks from hostile elements or failures due to inherent defects or exploited vulnerability increases the risk of significant impacts to healthcare, users, or patients depending on them. Cybersecurity has become of paramount importance in the development, approval, and commercialization of medical devices. The FDA, HealthCanada, the EU’s Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR), and Australia’s Therapeutic Goods Administration (TGA) all expect a holistic, risk-based approach to the design, manufacture, deployment, maintenance, and servicing of medical devices, with suitable and ever-vigilant cybersecurity protection ensuring trustworthy devices.

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